Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Phase 3CompletedNCT00206674

Genzyme, a Sanofi Company286 enrolled

Overview

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

286

Conditions

Crohn Disease

Interventions

Sargramostim (Leukine)DRUG

6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks

PlaceboDRUG

Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stable but active Crohn's disease at the time of screening * Must be able to self-inject or have another person who can help with the injection Exclusion Criteria: * Not have a colostomy or ileostomy * Not be taking prohibited medications as defined in the protocol * Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months * Not have ever taken this drug or drugs of similar type in the past

Locations (70)

Outcomes

Primary Outcomes

Induction of clinical response and/or remission as defined by decrease in CDAI score

Time frame: After 8 weeks of treatment

Secondary Outcomes

Time and duration to response/remission

Time frame: During the 8 weeks of treatment

QoL (different methods)

Time frame: During the whole study

Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)

Time frame: About 20 months

Data from ClinicalTrials.gov

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Buenos Aires, Buenos Aires F.D., Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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Garran, Australian Capital Territory, Australia

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Concord, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Sydney, New South Wales, Australia

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Sydney, New South Wales, Australia

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Brisbane, Queensland, Australia

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Brisbane, Queensland, Australia

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Adelaide, South Australia, Australia

...and 60 more locations